Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-09 @ 10:48 AM
Study NCT ID:
NCT00246805
Status:
COMPLETED
Last Update Posted:
2011-09-28
First Post:
2005-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'giovanna.zucchi@medtronic.com', 'phone': '+39 02 241371', 'title': 'Giorgio Corbucci - Sr Principal Scientist', 'organization': 'Medtronic BRC - Medtronic Italia'}, 'certainAgreement': {'otherDetails': "should INVESTIGATOR contemplate publishing/presenting, he shall provide copies of any abstracts, papers, or manuscripts to sponsor for review at least 30 days prior to submittal for publication or presentation. Sponsor shall limit its review to a determination of whether Confidential Information is disclosed and to check for technical correctness and shall not attempt to censor or in any way interfere with PARTICIPATING INSTITUTION's or INVESTIGATOR's presentation or conclusions", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'VRS ON', 'description': 'Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'VRS OFF', 'description': 'Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'HOSPITALIZATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'HOSPITALIZATION FOR HF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': "Evaluation of Rate Irregularity Indicators and Patient's Symptoms", 'timeFrame': 'January 2009', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation', 'timeFrame': 'January 2009', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate', 'timeFrame': 'January 2009', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization', 'timeFrame': 'January 2009', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VRS ON', 'description': 'Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)'}, {'id': 'OG001', 'title': 'VRS OFF', 'description': 'Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)'}], 'classes': [{'title': 'Preference VRS ON', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Preference VRS OFF', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'No Preference', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48', 'ciLowerLimit': '36', 'ciUpperLimit': '61', 'groupDescription': 'VRS ON vs. VRS OFF', 'statisticalMethod': 'Z-test for proportions', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'June 2009', 'description': 'Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VRS ON', 'description': 'Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)'}, {'id': 'FG001', 'title': 'VRS OFF', 'description': 'Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'enrollment period: from january 2006 till november 2008'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VRS ON', 'description': 'Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)'}, {'id': 'BG001', 'title': 'VRS OFF', 'description': 'Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80', 'spread': '6', 'groupId': 'BG000'}, {'value': '80', 'spread': '6', 'groupId': 'BG001'}, {'value': '80', 'spread': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-23', 'studyFirstSubmitDate': '2005-10-28', 'resultsFirstSubmitDate': '2009-11-06', 'studyFirstSubmitQcDate': '2005-10-28', 'lastUpdatePostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-23', 'studyFirstPostDateStruct': {'date': '2005-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)', 'timeFrame': 'June 2009', 'description': 'Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.'}], 'secondaryOutcomes': [{'measure': "Evaluation of Rate Irregularity Indicators and Patient's Symptoms", 'timeFrame': 'January 2009'}, {'measure': 'Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation', 'timeFrame': 'January 2009'}, {'measure': 'Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate', 'timeFrame': 'January 2009'}, {'measure': 'Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization', 'timeFrame': 'January 2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Permanent atrial fibrillation', 'VVI(R) pacing', 'rate regularization'], 'conditions': ['Permanent Atrial Fibrillation']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Proclemer A et al, Registro Italiano Pacemaker e Defibrillatori. Bollettino Periodico 2001. G Ital Aritmol Cardiostim 2002;5:5-31.'}, {'pmid': '2449483', 'type': 'BACKGROUND', 'citation': 'Wittkampf FH, de Jongste MJ, Lie HI, Meijler FL. Effect of right ventricular pacing on ventricular rhythm during atrial fibrillation. J Am Coll Cardiol. 1988 Mar;11(3):539-45. doi: 10.1016/0735-1097(88)91528-8.'}, {'pmid': '9558685', 'type': 'BACKGROUND', 'citation': 'Lau CP, Jiang ZY, Tang MO. Efficacy of ventricular rate stabilization by right ventricular pacing during atrial fibrillation. Pacing Clin Electrophysiol. 1998 Mar;21(3):542-8. doi: 10.1111/j.1540-8159.1998.tb00096.x.'}, {'pmid': '15121077', 'type': 'BACKGROUND', 'citation': 'Mazzocca G, Giovannini T, Frascarelli F, Fabiani A, Burali A, Giappichini G, Bidi G, Bernabo D, Manfredini E, Corbucci G. Heart rate regularisation in patients with permanent atrial fibrillation implanted with a VVI(R) pacemaker. Europace. 2004 May;6(3):236-42. doi: 10.1016/j.eupc.2004.02.002.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).', 'detailedDescription': "The RARE PEARL is a multicenter prospective, randomized, double-blinded, crossover study.\n\nPrior entering the study the patient should be informed and should give his written consent. Besides he/she should meet all selection criteria. The Investigator has to check that all selection criteria are satisfied. Then the patient undergoes pacemaker implantation, receiving a pacemaker model C20 SSIR or T20 SSIR (or later). The ventricular lead must be bipolar independently of the manufacturer.\n\nAfter pacemaker implantation, a 45 days Stabilization Period is necessary to stabilize leads and drug therapy.\n\nAt the end of the stabilization period the patient is randomized to have VRS algorithm switched either ON or OFF. The 1° Study Phase ends after 2 months. Then a cross-over takes place: VRS algorithm is switched respectively OFF or ON and the 2° Study Phase is started. Also the 2° Study Phase ends after 2 months.\n\nThe randomization will be centralized: randomization lists will be generated and managed by the sponsor. Because the patients will undergo a QoL questionnaire at each crossover phase, they will have to be blinded about the status of their VRS setting. Similarly, also the co-investigators administering the QoL questionnaires have to be blinded about the status of VRS setting. Only the principal investigator knows if the VRS algorithm is ON or OFF. The principal investigator will be instructed not to inform the patient and the co-investigators administering QoL questionnaire about the setting until after the end of the study.\n\nThe co-investigator(s) responsible for QoL questionnaire should not perform the patient follow-up at 1° and 2° Study Phase, otherwise the patient is automatically excluded from the study.\n\nAfter the cross-over period (2 + 2 months) a Free Therapy Phase (3° Phase) starts. Device settings and drug therapy are left to the physician's discretion.\n\nOne year after implantation a final follow-up is scheduled. The study ends and the pacemaker can be programmed according to the physician's discretion."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has signed informed consent form\n* Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and at least 1 episode of rate irregularity in the last month\n* New York Heart Association (NYHA) Class I, II, III\n* Patient is able to comply with follow-up times and will comply with the protocol\n* \\> 18 years of age\n\nExclusion Criteria:\n\n* Paroxysmal atrial fibrillation\n* NYHA Class IV\n* Left ventricular ejection fraction (LVEF) \\< 35\n* Patients with unstable angina\n* Patients who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior to enrolment\n* Patient candidate for cardiac surgery, or coronary angioplasty (PTCA)\n* Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack (TIA) with permanent disability\n* Life expectancy \\< 12 months due to other medical conditions\n* Pregnancy\n* The patient is enrolled in any concurrent (drug and/or device) study'}, 'identificationModule': {'nctId': 'NCT00246805', 'acronym': 'RARE-PEARL', 'briefTitle': 'Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic BRC'}, 'officialTitle': 'Post Marketing Study on Heart Rate Regularization in Patients With Permanent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'RARE-PEARL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1. VRS ON', 'description': 'Patients with permanent atrial fibrillation implanted with VVI(R) pacemaker Vitatron model C20 SSIR or T20 SSIR were randomized to Function Ventricular Rate Stabilization (VRS) ON or OFF.\n\nThis arm (1) is randomized to Function Ventricular Rate Stabilization ON.', 'interventionNames': ['Device: Vitatron pacemaker C20 SSIR or T20 SSIR models']}, {'type': 'NO_INTERVENTION', 'label': '2. VRS OFF', 'description': 'Patients with permanent atrial fibrillation implanted with VVI(R) pacemaker Vitatron model C20 SSIR or T20 SSIR were randomized to Function Ventricular Rate Stabilization (VRS)ON or OFF.\n\nThis arm (2) is randomized to Function Ventricular Rate Stabilization OFF.'}], 'interventions': [{'name': 'Vitatron pacemaker C20 SSIR or T20 SSIR models', 'type': 'DEVICE', 'description': 'VRS: special function that automatically adapts pacing rate to regularize cardiac cycles', 'armGroupLabels': ['1. VRS ON']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57100', 'city': 'Livorno', 'state': 'LI', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - Ospedale Civile', 'geoPoint': {'lat': 43.54427, 'lon': 10.32615}}, {'zip': '02100', 'city': 'Rieti', 'state': 'RI', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - ospedale Civile', 'geoPoint': {'lat': 42.40476, 'lon': 12.85735}}, {'zip': '15011', 'city': 'Acqui Terme', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - Ospedale Civile', 'geoPoint': {'lat': 44.67552, 'lon': 8.46934}}, {'zip': '60020', 'city': 'Ancona', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - Az. Ospedaliera Umberto I', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '52100', 'city': 'Arezzo', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - USL 8', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'zip': '57023', 'city': 'Cecina', 'country': 'Italy', 'facility': 'Divisione di Cardiologia- Ospedale di Cecina', 'geoPoint': {'lat': 43.30621, 'lon': 10.51729}}, {'zip': '55043', 'city': 'Lido di Camaiore', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - Azienda USL 12 di Viareggio', 'geoPoint': {'lat': 43.90012, 'lon': 10.2269}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Divisione Clinicizzata di Cardiologia - Az. Ospedaliera Maggiore della Carita', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '15067', 'city': 'Novi Ligure', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - ASL 22', 'geoPoint': {'lat': 44.76246, 'lon': 8.787}}, {'zip': '56127', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - Azienda Ospedaliera Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '59100', 'city': 'Prato', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - Azienda USL 4', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}, {'zip': '10100', 'city': 'Torino', 'country': 'Italy', 'facility': 'Divisione di Cardiologia - Ospedale Maria Vittoria', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Verbania', 'country': 'Italy', 'facility': 'Ospedalr di Verbania', 'geoPoint': {'lat': 45.92136, 'lon': 8.55183}}], 'overallOfficials': [{'name': 'Giorgio Corbucci, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vitatron Medical Italia'}, {'name': 'Eraldo Occhetta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Maggiore della Misericordia - Novara'}, {'name': 'Gianfranco Mazzocca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale di Cecina (LI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic BRC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}